MAUDE Adverse Event Report: MPRI INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number	3889-28
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The patient reported that the protective covering came off the lead when doctor was pulling the boot over the extension during the stage 1.No troubleshooting was performed.The lead was visible broken.We had to place another lead.The was no surgical or intervention planned or occurred.The issue was resolved.No further complications were reported/anticipated.
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
No new information reported.
Additional Manufacturer Narrative
Analysis of the lead model 3889-28 lot # va1gex3 showed the outer insulation was separated at the butt joint near the proximal end of the lead.Electrical testing determined the continuity was acceptable and no electrical shorts were identified.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6919504
• Report Number: 2649622-2017-10231
• Device Sequence Number: 873703
• Product Code: EZW
• UDI-Device Identifier: 00643169651111
• UDI-Public: 00643169651111
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/21/2021
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1GEX3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2017
• Supplement Date Received by Manufacturer: 10/25/2017; 11/17/2017
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 10/26/2017; 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 78